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WO2007133985A3 - Abnormal output detection system for a biosensor - Google Patents

Abnormal output detection system for a biosensor Download PDF

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Publication number
WO2007133985A3
WO2007133985A3 PCT/US2007/068320 US2007068320W WO2007133985A3 WO 2007133985 A3 WO2007133985 A3 WO 2007133985A3 US 2007068320 W US2007068320 W US 2007068320W WO 2007133985 A3 WO2007133985 A3 WO 2007133985A3
Authority
WO
WIPO (PCT)
Prior art keywords
biosensor
output signal
detection system
abnormal
normalized
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/068320
Other languages
French (fr)
Other versions
WO2007133985A2 (en
Inventor
Scott E Carpenter
Christine D Nelson
Huan-Ping Wu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Healthcare LLC
Original Assignee
Bayer Healthcare LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to HK09110880.3A priority Critical patent/HK1132643B/en
Priority to JP2009510115A priority patent/JP5121822B2/en
Priority to CA2650880A priority patent/CA2650880C/en
Priority to CN2007800162447A priority patent/CN101437443B/en
Priority to EP07783344A priority patent/EP2020909A2/en
Priority to MX2008014250A priority patent/MX2008014250A/en
Priority to BRPI0711433-8A priority patent/BRPI0711433A2/en
Application filed by Bayer Healthcare LLC filed Critical Bayer Healthcare LLC
Publication of WO2007133985A2 publication Critical patent/WO2007133985A2/en
Publication of WO2007133985A3 publication Critical patent/WO2007133985A3/en
Priority to US12/253,440 priority patent/US8234076B2/en
Anticipated expiration legal-status Critical
Priority to NO20084960A priority patent/NO20084960L/en
Priority to US13/536,310 priority patent/US9301717B2/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001—Enzyme electrodes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3273—Devices therefor, e.g. test element readers, circuitry
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
    • G16B20/00—ICT specially adapted for functional genomics or proteomics, e.g. genotype-phenotype associations
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
    • G16B5/00—ICT specially adapted for modelling or simulations in systems biology, e.g. gene-regulatory networks, protein interaction networks or metabolic networks
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16C—COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE
    • G16C20/00—Chemoinformatics, i.e. ICT specially adapted for the handling of physicochemical or structural data of chemical particles, elements, compounds or mixtures
    • G16C20/10—Analysis or design of chemical reactions, syntheses or processes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Optics & Photonics (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biotechnology (AREA)
  • Theoretical Computer Science (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Immunology (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Evolutionary Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Electrochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • General Physics & Mathematics (AREA)
  • Physiology (AREA)

Abstract

A biosensor has an abnormal output detection system that determines whether an output signal from the redox reaction of an analyte has a normal or abnormal shape or configuration. The abnormal output detection system improves the accuracy and precision of the biosensor in determining whether an output signal has a shape or configuration that may not provide an accurate and/or precise analysis of a biological fluid. The biosensor generates an output signal in response to the redox reaction of the analyte. The biosensor normalizes the output signal and compares the normalized output signal with one or more control limits. The biosensor may generate an error signal when the normalized output signal is not within the control limits. The system finds particular application in gated amperometry for glucose determination using enzyme electrodes, where the normalized signal comprises the ratio of two current values in a given pulse.
PCT/US2007/068320 2006-05-08 2007-05-07 Abnormal output detection system for a biosensor Ceased WO2007133985A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
BRPI0711433-8A BRPI0711433A2 (en) 2006-05-08 2007-05-07 Abnormal output detection system for a biosensor
CA2650880A CA2650880C (en) 2006-05-08 2007-05-07 Abnormal output detection system for a biosensor
CN2007800162447A CN101437443B (en) 2006-05-08 2007-05-07 abnormal output detection system for a biosensor
EP07783344A EP2020909A2 (en) 2006-05-08 2007-05-07 Abnormal output detection system for a biosensor
MX2008014250A MX2008014250A (en) 2006-05-08 2007-05-07 Abnormal output detection system for a biosensor.
HK09110880.3A HK1132643B (en) 2006-05-08 2007-05-07 Abnormal output detection system for a biosensor
JP2009510115A JP5121822B2 (en) 2006-05-08 2007-05-07 Abnormal output detection system for biosensor
US12/253,440 US8234076B2 (en) 2006-05-08 2008-10-17 Abnormal output detection system for a biosensor
NO20084960A NO20084960L (en) 2006-05-08 2008-11-26 Biosensor for abnormal signal detection
US13/536,310 US9301717B2 (en) 2006-05-08 2012-06-28 Determining analyte concentrations in biological fluids with abnormal output detection

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US74677106P 2006-05-08 2006-05-08
US60/746,771 2006-05-08

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/253,440 Continuation US8234076B2 (en) 2006-05-08 2008-10-17 Abnormal output detection system for a biosensor

Publications (2)

Publication Number Publication Date
WO2007133985A2 WO2007133985A2 (en) 2007-11-22
WO2007133985A3 true WO2007133985A3 (en) 2008-01-10

Family

ID=38543641

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/068320 Ceased WO2007133985A2 (en) 2006-05-08 2007-05-07 Abnormal output detection system for a biosensor

Country Status (11)

Country Link
US (2) US8234076B2 (en)
EP (1) EP2020909A2 (en)
JP (2) JP5121822B2 (en)
CN (1) CN101437443B (en)
BR (1) BRPI0711433A2 (en)
CA (1) CA2650880C (en)
MX (1) MX2008014250A (en)
NO (1) NO20084960L (en)
RU (1) RU2465812C2 (en)
TW (1) TWI431273B (en)
WO (1) WO2007133985A2 (en)

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US9008744B2 (en) 2011-05-06 2015-04-14 Medtronic Minimed, Inc. Method and apparatus for continuous analyte monitoring
CN102854232B (en) * 2008-12-08 2015-12-02 拜尔健康护理有限责任公司 There is the bio-sensor system of signal conditioning functions
US9274078B2 (en) 2006-03-31 2016-03-01 Lifescan, Inc. Systems and methods of discriminating control solution from a physiological sample
US10345255B2 (en) 2007-12-10 2019-07-09 Ascensia Diabetes Care Holdings Ag Rapid-read gated amperometry devices

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US8778168B2 (en) 2007-09-28 2014-07-15 Lifescan, Inc. Systems and methods of discriminating control solution from a physiological sample
EP2223104B1 (en) 2007-12-10 2018-08-29 Ascensia Diabetes Care Holdings AG Slope-based compensation
WO2009076302A1 (en) 2007-12-10 2009-06-18 Bayer Healthcare Llc Control markers for auto-detection of control solution and methods of use
US8603768B2 (en) 2008-01-17 2013-12-10 Lifescan, Inc. System and method for measuring an analyte in a sample
US8551320B2 (en) 2008-06-09 2013-10-08 Lifescan, Inc. System and method for measuring an analyte in a sample
DE102009048811B4 (en) * 2009-10-08 2013-07-18 Eads Deutschland Gmbh Biosensor device with self-test device
MX2012010860A (en) 2010-03-22 2013-03-05 Bayer Healthcare Llc Residual compensation for a biosensor.
KR102068949B1 (en) 2010-06-07 2020-01-21 바이엘 헬쓰케어 엘엘씨 Slope-based compensation including secondary output signals
BR112012031375A2 (en) 2010-06-07 2016-10-25 Bayer Healthcare Llc filler management system below what is required for a biosensor
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EP2758039B1 (en) 2011-09-21 2018-01-24 Ascensia Diabetes Care Holdings AG Biosensor with error compensation
US9810688B2 (en) * 2013-03-15 2017-11-07 Robert Bosch Gmbh Smart glass slide for microarrays
US9080196B2 (en) * 2012-09-28 2015-07-14 Cilag Gmbh International System and method for determining hematocrit insensitive glucose concentration
US9005426B2 (en) 2012-09-28 2015-04-14 Cilag Gmbh International System and method for determining hematocrit insensitive glucose concentration
EP3276355B1 (en) * 2013-03-14 2020-05-06 Ascensia Diabetes Care Holdings AG Normalized calibration of analyte concentration determinations
CN105283757B (en) * 2013-03-15 2019-04-23 豪夫迈·罗氏有限公司 A fail-safe method for electrochemical measurement of an analyte and devices, devices and systems incorporating the same
CA2900572C (en) * 2013-03-15 2018-02-13 F. Hoffmann-La Roche Ag Methods of detecting high antioxidant levels during electrochemical measurements and failsafing an analyte concentration therefrom as well as devices, apparatuses and systems incorporting the same
CN104122882A (en) * 2013-04-24 2014-10-29 中烟机械技术中心有限责任公司 Fault diagnosis system of Balluff self-diagnostic type sensor
TWI567387B (en) 2014-09-12 2017-01-21 達爾生技股份有限公司 Examination method for detecting abnormal property of electrochemical test strip
CN105445341B (en) * 2014-09-12 2018-10-16 达尔生技股份有限公司 Method for detecting abnormality of electrochemical test strip
JP7062954B2 (en) * 2016-02-10 2022-05-09 ソニーグループ株式会社 Blood coagulation analyzer and blood coagulation analysis method
WO2018104835A1 (en) * 2016-12-05 2018-06-14 Ascensia Diabetes Care Holdings Ag Risk factor monitoring
KR102031340B1 (en) * 2018-03-14 2019-10-11 주식회사 필로시스 System, method, and device to measure blood glucose
US11382541B2 (en) 2018-11-16 2022-07-12 Medtronic Minimed, Inc. Miniaturized analyte sensor
CN112294318B (en) * 2019-08-02 2024-08-20 华广生技股份有限公司 Implantable micro biosensor and its manufacturing method
TWI870545B (en) * 2020-02-21 2025-01-21 美商半導體組件工業公司 Method for measuring a work electrode current, bidirectional potentiostat, and cell measurement system
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9274078B2 (en) 2006-03-31 2016-03-01 Lifescan, Inc. Systems and methods of discriminating control solution from a physiological sample
US10345255B2 (en) 2007-12-10 2019-07-09 Ascensia Diabetes Care Holdings Ag Rapid-read gated amperometry devices
CN102854232B (en) * 2008-12-08 2015-12-02 拜尔健康护理有限责任公司 There is the bio-sensor system of signal conditioning functions
US9008744B2 (en) 2011-05-06 2015-04-14 Medtronic Minimed, Inc. Method and apparatus for continuous analyte monitoring

Also Published As

Publication number Publication date
US9301717B2 (en) 2016-04-05
RU2465812C2 (en) 2012-11-10
US8234076B2 (en) 2012-07-31
TWI431273B (en) 2014-03-21
HK1132643A1 (en) 2010-03-05
CA2650880C (en) 2015-11-24
JP5121822B2 (en) 2013-01-16
TW200804805A (en) 2008-01-16
NO20084960L (en) 2008-11-26
CA2650880A1 (en) 2007-11-22
US20090099787A1 (en) 2009-04-16
JP2009536744A (en) 2009-10-15
MX2008014250A (en) 2008-11-26
EP2020909A2 (en) 2009-02-11
JP2012255803A (en) 2012-12-27
CN101437443B (en) 2011-11-30
JP5373948B2 (en) 2013-12-18
CN101437443A (en) 2009-05-20
BRPI0711433A2 (en) 2011-11-16
RU2008148133A (en) 2010-06-20
US20120271559A1 (en) 2012-10-25
WO2007133985A2 (en) 2007-11-22

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